FDA approves an Amgen BLA for Kanjinti (trastuzumab-anns), the fifth biosimilar copy of Roches Herceptin (trastuzumab).
FDA says Teva has added seven lots of losartan potassium tablets to its recalled angiotensin II receptor blockers.
The European Medicines Agency says Luxembourg and the Netherlands have been added to the FDA-European Union mutual recognition agreement for current g...
FDA announces a temporary six-month program to provide rapid information to stakeholders on regulation of human cells, tissues, and cellular and tissu...
FDA posts a draft guidance on Mouse Embryo Assay for Assisted Reproduction Technology Devices.
Federal Register notice: FDA posts a list of information collections that have been recently approved by OMB.
CDER biotechnology products director Steven Kozlowski says requiring biologics manufacturers to obtain a USP monograph for their products could stifle...
FDA accepts for priority review a Genentech supplemental BLA for Rituxan (rituximab) for combination use with glucocorticoids for treating granulomato...